Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-28 @ 12:41 PM
Study NCT ID:
NCT00358592
Status:
UNKNOWN
Last Update Posted:
2013-05-21
First Post:
2006-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Tissue Retractors During Cesarean Delivery in Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-20', 'studyFirstSubmitDate': '2006-07-31', 'studyFirstSubmitQcDate': '2006-07-31', 'lastUpdatePostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time'}], 'secondaryOutcomes': [{'measure': 'blood loss'}, {'measure': 'number of transfusions'}, {'measure': 'infectious morbidity'}, {'measure': 'incision length'}, {'measure': 'intra and postoperative antiemetic medication use'}, {'measure': 'intra and postoperative pain medication use'}, {'measure': 'surgeon satisfaction'}]}, 'conditionsModule': {'keywords': ['surgical instruments', 'cesarean section', 'obesity'], 'conditions': ['Cesarean Section', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial comparing the use of the Mobius™ retractor to the use of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women. The Mobius™ retractor was designed for abdominal surgery to improve visualization of the surgical field through standard surgical incisions and is now a standard instrument used for cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of the Mobius™ retractor during cesarean deliveries in obese women decreases operative time, blood loss, number of transfusions, infectious morbidity, incision length, and intra- / post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.', 'detailedDescription': 'The Mobius™ retractor has been used in many obese cesarean deliveries based on the theory that it provides superior visualization. There have been no clinical trials to determine if this "added" exposure offers any measurable significant benefits to justify the added cost. This study will determine if the Mobius™ retractor does provide a measurable difference in outcomes, compared to the traditional retraction instruments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women undergoing non-urgent cesarean delivery\n\nExclusion Criteria:\n\n* women undergoing urgent cesarean delivery\n* BMI \\<35kg/m2\n* women undergoing vaginal delivery\n* positive urine drug screen or known history of methadone maintenance or substance abuse'}, 'identificationModule': {'nctId': 'NCT00358592', 'briefTitle': 'Comparison of Tissue Retractors During Cesarean Delivery in Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Randomized Controlled Trial of the Efficacy of the Mobius ™ Retractor in Performing Cesarean Sections in Patients With BMI ≥35kg/m2', 'orgStudyIdInfo': {'id': '06C.78'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mobius™ retractor', 'type': 'DEVICE'}, {'name': 'traditional metal retraction instruments', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason K Baxter, MD, MSCP', 'role': 'CONTACT', 'email': 'jason.baxter@jefferson.edu', 'phone': '215-955-9238'}, {'name': 'Edward J Hayes, MD', 'role': 'CONTACT', 'email': 'edwardjhayes@comcast.net', 'phone': '(215) 955-9196'}, {'name': 'Jason K Baxter, MD, MSCP', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Edward J Hayes, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Jason K Baxter, MD, MSCP', 'role': 'CONTACT', 'email': 'jason.baxter@jefferson.edu', 'phone': '(215) 955-9238'}, {'name': 'Edward J Hayes, MD', 'role': 'CONTACT', 'email': 'edwardjhayes@comcast.net', 'phone': '(215) 955-9196'}], 'overallOfficials': [{'name': 'Jason K Baxter, MD, MSCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Apple Medical Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}